12 Starting position: Position paper of the Federal Ministry of Health on the Revision of the European Directive concerning medical devices under the motto: Restoring trust in medical devices Patient safety must be our highest priority March 2013 Ever since the PIP breast implant scandal became public in December 2011, a discussion has been taking place in Europe on the safety of medical devices. Sadly, in addition to PIP, further incidents involving medical devices have also occurred: metal-on-metal hip replacements or stents inserted into the brain or coronary arteries. Even though sweeping suspicions of the manufacturers of medical devices are not justified, these and other cases are taken as an opportunity to express doubts about the safety and the medical benefit of medical devices in general. At the same time, proposals for amending the relevant statutory framework conditions are also being made since this could be a means of restoring patients' lost faith in the safety of medical devices. Now, in March 2013, the demand that the market access of high-risk medical devices (especially implants) should be regulated in the same way as for medicinal products (medicines) in other words in a state marketing authorisation process continues to be the focal point of discussion. However, what concrete improvements this is likely to bring for patients has not yet been sufficiently demonstrated. What we need is long-term and realistic solutions which are able to produce, in the nearest possible future, a tangible improvement in safety and proof of the medical benefit which patients gain from medical devices while, at the same time, facilitating speedier access to innovative medical devices for the benefit of patients. These solutions should be sought primarily in the current market access and surveillance systems since every system change would involve years of transition. Seite 12 von 30

13 In order to achieve the above-mentioned goals, all topics relevant to patient safety and patient benefit must be put to the test. In each case, we must pinpoint the precise cause of the problem that is identified: In the PIP case, it was criminal activity on the part of the manufacturer. With the metal-on-metal hip replacements, the diminished wear lifespan of the hip implant in younger patients (due to increased metal abrasion) only became evident after several years. In the case of brain stents (for stroke prevention), it is argued that lower-risk pharmacotherapy is now available and, as a result (at least now), the originally positive benefit-risk balance no longer applies for this medical device. The next step would be to examine which measures might have been able to prevent, or at least minimise, the consequences of the above-mentioned problems. In all honesty, it should be mentioned here that no one can seriously guarantee one hundred percent safety. Every decision to grant a marketing authorisation for a medical device or a medicinal product is based on a positive risk-benefit assessment. In this context, risks can seldom be completely ruled out. Irrespective of the quest for ways to improve the system based on an analysis of the root causes of the above-mentioned incidents, it can be observed that the critical public debate of the past months has challenged the public's confidence in the safety and reliability of medical devices. The debate centres on the charge that the procedures to grant market access to medical devices simply are not strict enough on the whole. In response to these reservations, the opportunity should be used to take another careful look at the regulations governing medical devices (market access, surveillance). All of the improvement proposals thus elaborated would need to be differentiated according to whether amendments to the relevant European legislation are required or whether action can be taken on a purely national level. At the end of September 2012, the European Commission submitted proposals for a: Seite 13 von 30

14 Regulation of the European Parliament and of the Council on medical devices and amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 as well as a Regulation of the European Parliament and of the Council on in-vitro diagnostic medical devices that are intended to replace the three Directives concerning medical devices hitherto in force (90/385/EEC, 93/42/EEC and 98/79/EC). The Federal Ministry of Health explicitly supports the aim of these proposals which is to create a robust and efficient legal framework that promotes innovation and allows patients fast access to innovative products on the one hand, while guaranteeing product safety and patient benefit, on the other. On the whole, the Draft Regulations contain many potential solutions capable of further developing and improving the legal framework for medical devices and in-vitro diagnostic medical devices based on the experience gained so far. The subsequent consultations present an opportunity to introduce adjustments and corrections. Germany sees the following as priority areas for the improvement of patient safety. Some of these have already been taken up by the Commission. Some aspects are seen differently by Federal Ministry of Health, others are being put forward additionally for discussion: 1. Requirements for medical devices I The case of the metal-on-metal hip replacements shows that we must carefully examine whether specific product requirements resulting from the essential requirements and the product standards are sufficient when seen from the perspective of patient safety. Consequently, we should immediately examine whether it is possible to significantly reduce or even prevent such undesired developments by introducing additional requirements for clinical trials and/or laboratory testing. The concrete consequence would be: The convening of an independent scientific expert group must be established in the regulations. The task of this group would be to take a critical look at all of the relevant standards/essential requirements for high-risk medical devices (especially implants) and to put forward proposals for improvement. This also includes the question of Seite 14 von 30

15 when and how clinical trials must be conducted on 'new' devices. Today's albeit restricted, but still at least existing legal possibility, of simply referring to clinical trials or clinical experience gained with comparable devices when seeking market access for new devices, must be restricted even further. In addition, requirements for the design of clinical trials that are specific to medical devices must be elaborated (as done by the FDA in the United States). It must be possible to make the requirements elaborated by the experts legally binding through appropriate European procedures (for example through instruments such as the current common technical specifications for in-vitro diagnostic medical devices). 2. Requirements for medical devices II In recent months, the question has been asked repeatedly, especially in statutory health insurance circles and by some members of the medical profession, whether a medical device's benefit for the patient is sufficiently proven at the time when that device is granted access to the market. This situation calls for unambiguous clarification. The concrete consequence would be: The positive risk-benefit assessment which is currently already mandatory for medical devices must be made more concrete. In assessing the risk and the clinical benefit of high-risk devices (especially implants), the risk-benefit profile of other medical procedures and/or types of devices should also be taken into consideration. 3. Requirements for Notified Bodies The pivotal components of a functioning and reliable system are, alongside the manufacturer's basic responsibility for his/her products, independent notified bodies working to the highest standards. This requires stricter requirements that are harmonised EU-wide with regard to the staffing, expertise and technical equipment of the notified bodies, as well as a Europe-wide standardised procedure for the notification of such bodies by state authorities, so as to ensure that all notified bodies meet the stricter requirements on a permanent basis. Furthermore, the supervision of the work done by Seite 15 von 30

16 the notified bodies must be conducted by the competent authorities in the Member States to the highest standards, EU-wide in a consistent and co-ordinated manner. The framework conditions needed to achieve this must be created. In this regard, the Federal Ministry of Health welcomes the Commission's proposals as contained in the Draft Regulations, in principle, and is in favour of swift decisions which, however, are yet to be specified in detail. This applies in particular to the existing possibilities for imposing sanctions on the notified bodies - up to and including the restriction or even the revocation of the notification by order of the Commission - that must be examined to determine their practicability. Furthermore, the notified bodies must be clearly and unmistakeably required in addition to their annual audits of manufacturers to also conduct unannounced product testing so as to ensure that the currently manufactured devices correspond to the devices 'authorised' by the notified bodies (and/or their Technical Documentation). The concrete consequence would be: The Federal Ministry of Health supports the Commission's proposal in principle. More detailed wording will need to be elaborated at a later stage of the procedure. 4. Intensification of surveillance In addition to strict requirements regarding the criteria for market access, we need to see improvements in another central component of the system to regulate medical devices (post-marketing-) surveillance. This calls for the creation of a co-ordinating mechanism to ensure the uniform interpretation and implementation of the European criteria as well as a co-ordinating committee to draw up a Europe-wide market surveillance programme comprising routine and non-routine (situation-triggered) inspections of manufacturers as well as unannounced sampling and testing of samples on the market by the competent authorities. The concrete consequence would be: The regulations must provide for mechanisms/procedures to achieve improved and standardised market surveillance, EU-wide, by the competent national authorities. Moreover, in the future, European market surveillance programmes must provide for the mandatory, unannounced, random control of implants and Class III and IIb de Seite 16 von 30

17 vices by the competent authorities in health care facilities and in the marketplace. Product testing is to be conducted as necessary. 5. Traceability of medical devices In connection with the PIP scandal, it became clear that affected patients must be identified more quickly. This logically entails improvements in the traceability of medical devices. In future, all manufacturers must label their devices with a unique, machine-readable code (UDI Unique Device Identifier). This includes the depositing of essential product data regarding this code into an EU database that is at the disposal of all parties involved (authorities, distributors, hospitals, health insurance funds, users, etc.). Furthermore, it will be necessary to make it mandatory for all parties involved to use the UDI during the device's 'life cycle' and to fulfil the documentation obligations (supply chain, intervention, billing, explantation, scrapping, register etc.). In addition, European legislation will have to stipulate, as an essential requirement for implantable medical devices, that affected patients (as is the case with Class IIa and higher custom-made devices) must be issued with an implant pass that contains essential information on the implant and its identification something which is currently required only in a few isolated product standards. The concrete consequence would be: The Federal Ministry of Health welcomes the fact that the regulations have addressed the improvement of medical device traceability and the clear identification of medical devices that would come from the creation of a worldwide, standardised system for the unambiguous identification of these devices. The Federal Ministry of Health strongly advocates that this system be introduced as soon as possible - at least for implantable medical devices. The transitional periods are to be restricted to the absolute minimum. The doctor or clinic involved is to provide the patient with an implant pass as well as a patient leaflet containing all the relevant data concerning their implant, such as durability and the intervals for follow-up examinations. Owing to the high level of bureaucracy involved, implant passes should be restricted to specific implants to be named concretely. Germany will be tabling an amendment in this regard. Seite 17 von 30

18 6. Registry Experiences in some European and non-european states show that the quality of care can be significantly improved with the help of registries, in particular implant registries. Instead of numerous incompatible and isolated European solutions, we need either a 'central European registry' or, at least, national registries set up according to the same criteria. The concrete consequence would be: Member States should voluntarily set up implant registries, with a uniform minimum data set, to which clinics or doctors can submit all implants that are suitable for registration along with information on the type, serial number, place and date of the implantation as well as pseudonymised patient data so that, alongside the long-term monitoring of implanted devices, the traceability back to the clinic or the doctor is guaranteed or a means of informing patients accordingly is ensured in an emergency. 7. Reprocessing of medical devices Improperly reprocessed medical devices have repeatedly been the source of negative headlines in Germany in recent years and have led to concern among patients. In resolving the cases in question, it was revealed that, almost exclusively, devices labelled by the manufacturer as reprocessable medical devices were involved. At the root of the problems was the failure to observe the strict standards laid down in the Recommendation of the Commission for Hospital Hygiene and Infection Prevention of the Robert Koch Institute and the Federal Institute for Drugs and Medical Devices concerning the 'Hygienic Requirements for the Reprocessing of Medical Devices'. This has two implications: 1. We need stricter standards for the reprocessing of medical devices, and 2. The observance of these standards must be subjected to strict surveillance. However, comprehensive patient protection can only be guaranteed if these standards are not observed in Germany alone but at least also in Europe as a whole. The focus which the EU directives have placed until now on the so-called medical devices in Seite 18 von 30

19 tended for single use does not respond to this concern since it leaves the overwhelming majority of medical devices unregulated in this decisive area. This is why the Commission's approach goes in the wrong direction. Whether or not the following approach can be implemented within the framework of the new Medical Devices Regulations or whether another (separate) legal instrument is necessary will have to be examined by the competent bodies. The concrete consequence would be: The Federal Ministry of Health believes that the Commission's current considerations as set out in Article 15 of the Regulation on the reprocessing of 'single-use' medical devices are not sufficient for ensuring comprehensive patient protection. Instead, the reprocessing of medical devices should be regulated in a way that does not discriminate between 'single-use' and 'multiple-use' devices. Consequently, the essential requirements for the information on the reprocessing process that the manufacturer must provide should be more concretely specified. Moreover, Member States should be obliged to adopt national regulations for the proper reprocessing of all medical devices without delay. In the case that some Member States still do not endorse the reprocessing of so-called 'single-use' devices, they should be allowed to prohibit this practice. However, the regulations may not stipulate this as a binding requirement for all Member States. If consensus on this matter is impossible to reach, Article 15 should be dispensed with on grounds of subsidiarity. 8. Securing acceptance of the CE marking The national and European public debate on the medical devices system has revealed that public trust in the CE marking of these products is shaken. The so-called New Approach to product regulation covers 24 product groups. These are perceived by the consumers to also include products, mainly imported ones, that are of an inferior quality. As a result, it is hard to communicate that the CE marking on medical devices does not only attest to their safety, but also to their quality and patient benefit. The CE marking of medical devices is widely mistrusted, not least because this system is hardly understood in its entirety. Overall, therefore, it can be said of the medical devices sector that, contrary to expectations, use of the CE marking has not proven use ful for these products. It has not been possible to convince the parties involved that Seite 19 von 30

20 there is more to the conformity assessment of these products - the prerequisite for affixing the CE marking - than examinations of technical safety. There is no awareness of the link that exists between the stringent requirements for the evidence of efficacy and the acceptability of the benefit/risk balance that this product group must also satisfy in addition to high safety and security requirements and the granting of the CE marking. The market access procedure for medical devices is perceived to be on a level similar to that for toys or other articles of daily use.what is needed here is a new beginning. Specifically, a visibly different European seal of quality and approval for medical devices as evidence of utmost patient safety. The concrete consequence would be: A new EU-wide seal of quality and approval, for instance CE Med, should be introduced to replace the existing CE marking. The purpose of this seal of quality and approval would be to affirm that the medical devices in question fulfil the highest safety requirements and that their efficacy and patient benefit have been proven. In order to obtain this seal, every manufacturer will be required to operate a quality management system (QM system) that has been certified by a notified body. In addition, all highrisk medical devices (among them all critical implants) will have to undergo premarketing testing by specially qualified notified bodies. Medium-risk devices must undergo representative product testing in addition to the certification of the QM system. Moreover, the notified bodies will have to carry out unannounced product testing. The proposal includes the demand that manufacturers of Class I medical devices (nursing home beds, patient fixation systems, wheelchairs etc.) will have to operate a quality management system that has been certified by a notified body. Whether (and if yes, which) exemptions for Class I medical devices will be necessary and feasible in an effort to protect small and medium-sized companies will have to be examined in the course of the procedure after hearing the parties involved. Seite 20 von 30

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